| CTRI Number |
CTRI/2024/11/076157 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFICACY OF COMPREHENSIVE OCULAR EXERCISES MODULE (I-EXERCISES) ON VISUAL EVOKED POTENTIAL(VEP), EYE FATIGUE AND VISUAL ACUITY IN MYOPIA
|
|
Scientific Title of Study
|
Efficacy Of Comprehensive Ocular Exercises Module (I-EXERCISES) On Visual Evoked Potential (VEP), Eye Fatigue And Visual Acuity In Myopia
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhvani Shah |
| Designation |
Assistant Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Ayurvihar Complex, Eastern Express highway, Sion, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA
400077
India |
| Phone |
9820149921 |
| Fax |
|
| Email |
sdhvani7@somaiya.edu |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DR BHAVANA GADHAVI |
| Designation |
DEAN AND PRINCIPAL |
| Affiliation |
PARUL UNIVERSITY |
| Address |
PARUL UNIVERSITY, PARUL COLLEGE OF PHYSIOTHERAPY,POST LIMDA, WAGHODIA, GUJARAT 391760
PARUL UNIVERSITY, PARUL UNIVERSITY OF PHYSIOTHERAPY, POST LIMDA, WAGHODIA, GUJARAT 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9727729787 |
| Fax |
|
| Email |
bhavana.gadhavi28222@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhvani Shah |
| Designation |
Assistant Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai, Maharashtra 400022
MAHARASHTRA
400077
India |
| Phone |
9820149921 |
| Fax |
|
| Email |
sdhvani7@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| K J SOMAIYA COLLEGE OF PHYSIOTHERAPY,Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai, Maharashtra India 400022 |
|
|
Primary Sponsor
|
| Name |
Dr Dhvani Shah |
| Address |
Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai, Maharashtra 400022 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR DHVANI SHAH |
K J Somaiya College of Physiotherapy |
SOMAIYA AYURVIHAR COMPLEX, EASTERN EXPRESS HIGHWAY, CHUNABHATTI, SION, MUMBAI:400022
Mumbai
MAHARASHTRA |
9820149921
dhvani@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K J SOMAIYA MEDICAL COLLEGE & HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
new developed I- exercises through delphi study |
Exercise protocol for 6 weeks will be given to the interventional group and outcome measure will be recorded pre , post and 2 weeks follow up after 6 weeks |
| Comparator Agent |
the control group will not be given any eye exercises |
Control group is also of Myopia patients but no exercises will be given to the control group. The control group will continue with the conventional treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
- Students
- Myopia refractive errors more than 1 year
- 1 eye or both eyes involvement (Higher myopia will be included)
- Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
- Daignosis with diabetes/ thyroid disorders
- Presence of intellectual disability
- lasik surgeries
- Any pathological eye conditions, dry eyes, congenital eye abnormalities
- Any other refractive errors |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual evoked potential |
baseline, 6 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| eye fatigue questionnaire |
Pre intervention , postintervention ( 6 weeks ) and 12 weeks follow up |
|
|
Target Sample Size
|
Total Sample Size="197"
Sample Size from India="197"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The topic is "Efficacy of comprehensive ocular exercise module (I-exercises) on Visual evoked potential, eye fatigue questionnaire and visual evoked potential". The protocol will be finalized with 6 experts through Delphi technique. The subjects will be included based on the inclusion and exclusion criteria and will be randomly placed in interventional and control groups respectively. The outcome measures will be measured pre intervention and post intervention (3 weeks) |